Films for use as dosage forms

Abstract

Non gelatin film materials e.g. films of modified cellulose materials find use as dosage forms. Substances are incorporated into the film matrix and films thus prepared may be administered really, or otherwise internally, or epidermally. The administable form may comprise a matrix which contains at least one water soluble polymer in the form of a film, in addition to at least one active ingredient, to produce a therapeutic, organoleptic or cosmetic effect.

1 . A method of producing a single, discrete non-gelatin film comprising: 
 a) forming a non-gelatin polymeric film, with or without active ingredients incorporated therein;    b) applying a liquid to one or more surfaces of the film, said liquid incorporating at least one active ingredient; and    c) allowing the liquid applied to at least partially cure and associate with the film, to result in;    the fluid being absorbed within the film, wholly or partially, and forming a homogeneous polymer film product.    
   
   
       2 . A method according to  claim 1 , wherein the non-gelatin film produced comprises one or more layers which associate with one another to a lesser or greater degree to form a partially or wholly polymerically homogeneous film.  
   
   
       3 . A method according to  claim 1 , wherein the polymeric mass of the film or films is increased marginally or substantially after steps b) or c).  
   
   
       4 . (canceled)  
   
   
       5 . A method according to  claim 1  whereby one or more polymeric substances are also deposited on the film surface.  
   
   
       6 . A method according to  claim 1 , wherein the active ingredient in the liquid is transported onto or into the film during step c) of  claim 1 .  
   
   
       7 . A method according to  claim 2  wherein the active ingredient is selectively transported.  
   
   
       8 . A method according to  claim 1 , wherein the non-gelatin film comprises a cellulose ether film.  
   
   
       9 . A method according to  claim 1 , wherein the non-gelatin film comprises one or more of the following polymers: 
 hydroxypropyl methylcellulose (HPMC),    hydroxy propyl cellulose (HPC),    hydroxy ethyl methyl cellulose (HEMC),    hydroxy ethyl cellulose (HEC),    methyl cellulose (MC),    carboxy methylcellulose (CMC),    sodium carboxy methylcellulose    and salts and derivatives of all aforesaid.    
   
   
       10 . A method according to  claim 1 , wherein the liquid comprises a same or similar polymeric material as to which forms the non-gelatin film.  
   
   
       11 . A method according to  claim 1 , wherein the liquid comprises a material which is chemically or physically compatible with the material which forms the non-gelatin film.  
   
   
       12 . A method according to  claim 1 , wherein the active ingredient is transported from the liquid to the film.  
   
   
       13 . A method according to  claim 1 , wherein the active ingredient has a higher affinity for the liquid than the film.  
   
   
       14 . A method according to  claim 1 , wherein the film active ingredient has a higher affinity for the film than the liquid.  
   
   
       15 . A method according to  claim 10 , wherein  2  or more active ingredients have the same or differing affinities for the film and liquid.  
   
   
       16 . A film produced by the method in  claim 1 .  
   
   
       17 . (canceled)  
   
   
       18 . A film according to  claim 16 , wherein one or more active ingredients are present in the film and which have concentration gradients associated with one or more bands or patterns within the film.  
   
   
       19 . A film produced according to  claim 1 , wherein the active ingredient continues to move or be transported after the curing stage.  
   
   
       20 . A film according to  claim 16 , wherein one or more layers associate with one another to a lesser or greater degree to form a level of polymeric homogeneity.  
   
   
       21 . A film according to  claim 16 , which is coiled.  
   
   
       22 . A film according to  claim 16 , which is folded in a zig-zag formation.  
   
   
       23 . A pharmaceutical dosage form comprising multi-layers of film formed from films according to  claim 16 .  
   
   
       24 . A pharmaceutical dosage form according to  claim 23 , wherein the films are laid together before any liquid or transport medium applied has cured or dried.  
   
   
       25 . A film produced in accordance with  claim 1 , wherein the film is packaged to form a dose unit.  
   
   
       26 . A sheet of film produced in accordance with  claim 1 , wherein the film has liquid according to  claim 1  applied to it, on one or both sides, and on opposing/adjacent areas or non-opposing or adjacent areas or overlapping areas to form a pattern.  
   
   
       27 . A dosage form produced from a sheet of film wherein the pattern produced with respect to the film provides a delayed active drug release profile.  
   
   
       28 . A pharmaceutical dosage form derived from a film produced by a method according to  claim 1 .  
   
   
       29 . Use of a film according to  claim 16 , wherein the film is placed on the tongue of a human or animal and the active ingredients are released in a convenient manner as the film disintegrates.  
   
   
       30 . A tablet, powder slug or capsule made from or coated, enrobed or encapsulated with a film according to  claim 16 .  
   
   
       31 . A tablet or monolith made from multiple layers of film according to  claim 16 .  
   
   
       32 . A tablet or monolith according to  claim 25 , wherein said tablet or monolith comprises three to forty layers.  
   
   
       33 . A tablet or monolith according to  claim 25 , wherein said tablet or monolith comprises 8 to 25 layers.  
   
   
       34 . A tablet of monolith according to  claim 25 , wherein the tablet or monolith comprises 10 to 20 layers.  
   
   
       35 . A multicellular dosage form made from a film according to  claim 16 .  
   
   
       36 . A method according to  claim 10 , wherein said liquid comprises a material which is chemically or physically compatible with the material which forms the non-gelatin film, and wherein 2 or more active ingredients have the same or differing affinities for the film and liquid.  
   
   
       37 . A film according to  claim 18 , which is coiled.  
   
   
       38 . A film according to  claim 19 , which is coiled.  
   
   
       39 . A film according to  claim 20 , which is coiled.